Informations générales (source: ClinicalTrials.gov)
Cell Therapy for Inclusion Body Myositis (IBM) by Muscle Injection of Autologous Uncultured Adipose-Derived Stromal Vascular Fraction (ADSVF): a Phase I Trial
Interventional
Phase 1
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2023
avril 2024
03 décembre 2025
Inclusion Body Myositis is a slowly but disabling myopathy, the most frequent in patients
over 50 years old. No treatments (in particular immunosuppressive) are known to be
efficient.
Autologous uncultured adipose-derived stromal vascular fraction (ADSVF) is recognized as
an easily accessible (by a standard liposuction to obtain adipose tissue, from which
ADSVF are isolated by centrifugation), safe and well tolerated source of cells with
angiogenic, anti-inflammatory, immunomodulatory and regenerative properties. The purpose
of our ADSVF in IBM phase I trial is to evaluate, for the first time in human diseased
muscle, first the tolerance of autologous ADSVF cells locally injected in affected
forearm muscles and second their capability to repair those muscles. With always the
goals of tolerance first and second muscle repair, we will recruit in parallel two groups
of IBM patients: the first treated by sirolimus since at least 6 months (but still
disabled) and the second currently (for at least 3 months) without specific treatment for
inclusion myositis.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:21:23 | Contacter | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Olivier BENVENISTE - 75013 - Paris - France | Olivier BENVENISTE | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- With an age ≥ 45 and ≤ 80 yo.
- Man or menopausal woman. - With IBM defined by the Lloyd criteria (Lloyd et al.,
2014): muscle weakness of finger flexors or quadriceps, and endomysial inflammatory
infiltrates on muscle biopsy, and presence of invaded fibers or rimmed vacuoles on
muscle biopsy.
- Who gave their written informed consent
- Affiliated to a social security regime (expected AME) And for: -group 1: treated by
sirolimus since at least 6 months (but still disabled ) - group 2: currently (for at
least 3 months) without specific treatment for inclusion myositis.
- With an age ≥ 45 and ≤ 80 yo.
- Man or menopausal woman. - With IBM defined by the Lloyd criteria (Lloyd et al.,
2014): muscle weakness of finger flexors or quadriceps, and endomysial inflammatory
infiltrates on muscle biopsy, and presence of invaded fibers or rimmed vacuoles on
muscle biopsy.
- Who gave their written informed consent
- Affiliated to a social security regime (expected AME) And for: -group 1: treated by
sirolimus since at least 6 months (but still disabled ) - group 2: currently (for at
least 3 months) without specific treatment for inclusion myositis.
- Impossibility to walk 10 meters
- Grip evaluated by MRC5 MMT at 0 OR 1.
- Body mass index < 18
- Not able to stop any anticoagulant, or antiaggregant drugs within the week before
and the 48 hours before the liposuction
- Severe respiratory insufficiency (FVC < 50% and/or FEV1 < 50%)
- Severe chronic kidney disease (Estimated Glomerular Filtration Rate < 15 ml/min
and/or proteinuria > 0.5 g/24h)
- Cancer non in remission (necessitating specific treatment) during the past 12 months
- Connective Tissue Disease non in remission (necessitating specific treatment) during
the past 12 months - Bone marrow transplantation
- Connective Tissue disease non in remission (necessitating specific treatment) during
the past 12months - Immunosuppressive drugs except sirolimus, ongoing or stopped in
less than 3 months
- Polyvalent immunoglobulins (IV or sub-cut) ongoing or stopped in less than 3 months
- Any biotherapies (mAbs) such as ant-CD20, CTLA4Ig, anti-TNF, anti-IL6R, anti-IL1
etc... ongoing or stopped in less than 6 months.
- Seropositivity for HIV, HCV or HBV
- Contraindication to muscle MRI
- Contraindications to the liposuction: eg coagulation disorders, etc... -
Contraindications to anaesthetics
- Documented conventional antibiotics severe allergy such as ß-lactam (cephalosporin),
cyclins, macrolides (for example metronidazole), quinolones
- Participation in another trial (Jardé 1 or Jardé 2)
- Legal protection (curatorship or tutorship) or safety measure